Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
Sintilimab Combined With Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy vs. Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy for Total Neoadjuvant Therapy in Patients With Mismatch Repair-Proficient (pMMR) or Microsatellite Stable/Low Microsatellite Instability (MSS/MSI-L) Locally Advanced Rectal Cancer: A Multicenter, Randomized, Double-Blind, Controlled Phase III Study
This is a randomized, double-blind, controlled, Phase III clinical study to evaluate the efficacy and safety of sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy, which is planned to enroll 500 subjects with locally advanced rectal cancer.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Yanxi Pu
- 電話番号：+86-18523197816
- メール：yanxi.pu@innoventbio.com
研究場所
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510060
- Sun Yat sen University Cancer Center
-
コンタクト：
- Ruihua Xu
- 電話番号：+86-20-87343468
- メール：xurh2@sysucc.org.cn
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
- Histopathologically confirmed locally advanced rectal adenocarcinoma, with clinical stage cT3-4NanyM0 or cT1-2N1-2M0 as defined by the AJCC 8th edition, and assessed as amenable to R0 resection after neoadjuvant therapy. MRI demonstrates that the lower edge of the tumor is within 10 cm from the anal verge.
- Tumor pathological tissue testing confirms pMMR, i.e., immunohistochemical staining shows positive expression of all four proteins MLH1, MSH2, MSH6, and PMS2, or tumor tissue-based genetic testing indicates MSI-L or MSS.
- No signs of intestinal obstruction; or intestinal obstruction that has been relieved after proximal colostomy.
- No prior rectal surgery; no prior systemic anti-cancer therapy, or other investigational drug therapy.
- Age ≥18 years, both sexes eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Expected survival of ≥2 years.
- Adequate bone marrow and organ function. Exclusion Criteria
1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
2. Plans to receive other anti-tumor therapy during the treatment period of this study.
3. Receipt of any live vaccine within 4 weeks before the first dose of study drug, or plans to receive any live vaccine during the study period.
4. Presence of toxicity from prior therapy that has not recovered to Grade 0 or 1 per NCI CTCAE V6.0 before the first dose of study drug (excluding alopecia, fatigue, pigmentation, and other conditions judged by the investigator to pose no safety risk).
5. Major surgery 6. Receipt of immunosuppressive therapy within 4 weeks before the first dose of study drug, excluding topical corticosteroids administered intranasally, by inhalation, or by other local routes, or physiological doses of systemic corticosteroids , or corticosteroids used to prevent contrast agent allergy.
7. Recurrent rectal cancer; multiple primary colorectal cancers. 8. History of pelvic or abdominal radiotherapy.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Placebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
130 mg/m²，IV，Q3W 20 ml D1 IV Q3W PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) 825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； Radical resection of rectal cancer |
|
実験的：Sintilimab
sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
130 mg/m²，IV，Q3W PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) 825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； Radical resection of rectal cancer 200 mg D1 IV Q3W |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
EFS
時間枠：throutg treatment completion an average of 5 years
|
EFS refers to the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, death from any cause, etc. |
throutg treatment completion an average of 5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
OS
時間枠：throutg treatment completion an average of 5 years
|
OS is defined as the time from the date of randomization until the date of death from any cause. |
throutg treatment completion an average of 5 years
|
|
CCR
時間枠：up to 5 years after enrollment
|
CCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR) |
up to 5 years after enrollment
|
|
R0 resection rate
時間枠：up to 5 years after enrollment
|
R0 resection rate: Descriptive summary of R0 resection rate |
up to 5 years after enrollment
|
|
EFS3
時間枠：3yaers
|
EFS3 defined as the proportion of participants who remain free from any of the following events for 3 years after randomization: disease progression precluding surgery, local or distant recurrence, or death from any cause |
3yaers
|
|
TRG
時間枠：up to 5 years after enrollment
|
Pathological assessment of tumor regression grading (TRG) after neoadjuvant therapy |
up to 5 years after enrollment
|
|
neoadjuvant therapy completion rate
時間枠：up to 5 years after enrollment
|
Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate |
up to 5 years after enrollment
|
|
OPR
時間枠：up to 5 years after enrollment
|
The definition of organ preservation is: no radical total mesorectal excision (TME) performed, and no local regrowth, unless such regrowth can be salvaged by local excision achieving a limited, radical (R0) resection, with no permanent stoma (including a protective stoma that has never been reversed, or a stoma resulting from adverse events and/or poor functional outcome, or a permanent stoma). |
up to 5 years after enrollment
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CIBI308H301
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。